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A Clinical Trial to Asses Efficacy and Safety of Cord Blood Eye Drops in Neurotrophic Keratopathy

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ClinicalTrials.gov Identifier: NCT03084861
Recruitment Status : Recruiting
First Posted : March 21, 2017
Last Update Posted : July 16, 2019
Sponsor:
Information provided by (Responsible Party):
Banc de Sang i Teixits

Study Description
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Brief Summary:
This is a multicenter, randomized, open-label, two-arms phase I/II, clinical trial, in which 42 patients will be enrolled with the principal objective to evaluate the efficacy through changes in lesion size and, secondary, to evaluate the safety and efficacy through corneal sensibility, corneal opacity, visual acuity and complications of Neurotrophic Keratopathy (NK). Patients will be randomized 1:1 to receive experimental treatment (cord blood eye drops) or conventional treatment (artificial tears and therapeutic contact lens).

Condition or disease Intervention/treatment Phase
Neurotrophic Keratopathy Drug: Cord Blood Eye Drops Drug: Conventional treatment Phase 1 Phase 2

Detailed Description:

This is a multicenter, randomized, open-label, two-arms phase I/II, clinical trial, in which 42 patients will be enrolled with the principal objective to evaluate the efficacy through changes in lesion size and, secondary, to evaluate the safety and efficacy through corneal sensibility, corneal opacity, visual acuity and complications of NK. Patients will be randomized 1:1 to receive experimental treatment (cord blood eye drops) or conventional treatment (artificial tears and therapeutic contact lens).

All patients, with conventional or experimental treatment, will be treated for 19 days. A topical antibiotic will be added too as a concomitant treatment to all treatment groups, until the injury closes or according to medical criteria.

After signing informed consent, inclusion and exclusion criteria will be assessed, and if the patient meets all the requirements, the patient will be randomized.

After initiation of the treatment, patients will be follow-up at 2-3 days and once a week for 3 weeks. A final follow-up is planned at 6 weeks.


Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 42 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: open label
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Multicenter, Randomized, Open-label, Two-arms Phase I/II Clinical Trial to Asses Efficacy and Safety of Cord Blood Eye Drops in Neurotrophic Keratopathy
Actual Study Start Date : February 24, 2017
Estimated Primary Completion Date : December 1, 2022
Estimated Study Completion Date : June 1, 2023
Arms and Interventions
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Arm Intervention/treatment
Experimental: cord blood eye drops
Experimental drug: cord blood eye drops Description: eye drops plasma from cord blood diluted v/v with Plasmalyte®, without antimicrobial preservatives Dosage regimen: 1 drop every 2 hours Pharmaceutical form: ophthalmic preparation eye drops Presentation: batch of 19 vials of 1 mL per vial Route of administration: ophthalmic/ocular
 Drug: Cord Blood Eye Drops
Eye drops plasma from cord blood diluted v/v with Plasmalyte®, without antimicrobial preservatives
Active Comparator: Conventional treatment

Conventional treatment:

  1. Artificial tears Description: Lubristil ® (single dose) Dosage regimen: 1 drop every 2 hours Pharmaceutical form: ophthalmic preparation eye drops Presentation: batch of 20 or 30 vials of 0.3 mL per vial Route of administration: ophthalmic
  2. Therapeutic Contact lens Description: Air Optix Night&Day Dosage regimen: 1 contact lens per visit Pharmaceutical form: contact lens Presentation: 1 unit per case Route of administration: ophthalmic/ocular
 Drug: Conventional treatment
  1. Artificial tears: Lubristil ®
  2. Therapeutic Contact lens: Air Optix Night&Day


Outcome Measures
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Primary Outcome Measures :
  1. Corneal lesion size [ Time Frame: after 3 weeks post-treatment, ]
    Variation percentage in corneal lesion size


Secondary Outcome Measures :
  1. Incidence of Adverse Events [ Time Frame: From date of randomization until the date of the last visit (6 weeks post-treatment) ]
    Safety evaluation through laboratory data and adverse events

  2. Corneal lesion size [ Time Frame: at 2-3 days post-treatment and at 1, 2 and 6 weeks post-treatment ]
    Variation percentage in corneal lesion size

  3. Stage on the corneal lesion [ Time Frame: at 3 weeks post-treatment ]
    Changes stage on the corneal lesion (cured, stage 1, stage 2, stage 3) from baseline

  4. Qualitative scale of corneal sensibility [ Time Frame: at 2-3 days post-treatment and at 1, 2, 3 and 6 weeks post-treatment ]
    Changes in qualitative scale of corneal sensibility (normoesthesia, hypoesthesia, anesthesia)

  5. Corneal opacity [ Time Frame: at 2-3 days post-treatment and at 1, 2, 3 and 6 weeks post-treatment ]
    Changes on corneal opacity from baseline (not response, improvement, worse)

  6. Visual acuity [ Time Frame: at 2-3 days post-treatment and at 1, 2 and 6 weeks post-treatment ]
    Line variation in relation to visual acuity

  7. Neurotrophic keratopathy [ Time Frame: From date of randomization until the date of the last visit (6 weeks post-treatment) ]
    Number of neurotrophic keratopathy complications


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Age ≥ 18 years old
  2. NK stage 2 or 3 (Mackie classification)
  3. Signed Informed Consent Form
  4. The patient is able to understand the nature of the study and to participate throughout its duration

Exclusion Criteria:

  1. Medical history of eye tumors
  2. Active eye infection
  3. Eyelid bad position or eyelid closure problems
  4. Conjunctiva scarring
  5. Topic chronic eye treatments with corticoids
  6. Acute corneal burns (<3 months)
  7. Intolerance to contact lens
  8. Allergy or inability to receive concomitant treatment with Exocin®
  9. Patients with immunosuppressive or chemotherapy treatment
  10. Pregnant woman or woman without proper contraceptive methods according to the investigator (*), or lactating women
  11. Participation in another clinical trial in the last month (*) Contraceptive methods accepted in the protocol are: hormonal, intrauterine device (IUD), barrier methods, voluntary sterilization or the patient has menopause >1 year duration
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03084861


Contacts
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Contact: Dinara Samarkanova, MD +34935573500 ext 6563 dsamarkanova@bst.cat
Contact: Ruth Coll Bonet, MD +34935573500 ext 6707 rucoll@bst.cat

Locations
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Spain
Hospital Universitari Germans Trias i Pujol Recruiting
Badalona, Barcelona, Spain, 08916
Contact: Antonio Sabala, MD    34934978599    asabala.germanstrias@gencat.cat   
Hospital Mútua de Terrassa Recruiting
Terrassa, Barcelona, Spain, 08221
Contact: Miriam Barbany, MD    34937365050    mbarbany@mutuaterrassa.es   
Hospital de la Santa Creu i Sant Pau Recruiting
Barcelona, Catalonia, Spain, 08026
Contact: Zoraida Del Campo Carrasco, MD    +34935565775    ZCampo@santpau.cat   
Principal Investigator: Zoraida Del Campo Carrasco, MD         
Hospital Vall d'Hebron Recruiting
Barcelona, Catalonia, Spain, 08035
Contact: Javier Puig Galy, MD PHD    +34932746000    lospuig.javier@gmail.com   
Instituto Oftalmológico Quirónsalud Barcelona Recruiting
Barcelona, Spain, 08017
Contact: Marta Calatayud, MD    34902507902    marta.calatayud@quironsalud.es   
Hospital de l'Esperança Recruiting
Barcelona, Spain, 08024
Contact: Pablo Martí, MD    34933160602    pablomartirodrigo@hotmail.com   
Institut de microcirurgia ocular IMO Recruiting
Barcelona, Spain, 08035
Contact: Miriam Barbany, MD    34932531501    barbany@imo.es   
Hospital Clinic i Provincial de Barcelona Recruiting
Barcelona, Spain, 08036
Contact: Josep Torras, MD    34932275400 ext 4897    jtorras@clinic.cat   
Hospital Josep Trueta Not yet recruiting
Girona, Spain, 17007
Contact: Teresa Torrent, MD    34972210708 ext 228    33619tts@comb.cat   
Hospital Joan XXIII Recruiting
Tarragona, Spain, 43005
Contact: Daniela Ortiz, MD    34977759396    ortizvaquerizas@hotmail.com   
Sponsors and Collaborators
Banc de Sang i Teixits
Investigators
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Principal Investigator: Sergi Querol Giner, MD PHD Banc de Sang i Teixits
More Information
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Responsible Party: Banc de Sang i Teixits
ClinicalTrials.gov Identifier: NCT03084861     History of Changes
Other Study ID Numbers: I.2016.010
First Posted: March 21, 2017    Key Record Dates
Last Update Posted: July 16, 2019
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Ophthalmic Solutions
Pharmaceutical Solutions